MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

Catalog Number 00880100100

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The device has been returned to the manufacturer for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that the unit had malfunction.During the procedure, the instrument ran hot and caused harm to the patient: the patient was burned.The event occurred during surgery.Another dermatome was used to complete the surgery; an additional graft was not needed.No additional patient consequences were reported.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).Reported issue: on (b)(6) 2019, it was reported that the unit had malfunction.During the procedure the instrument ran hot and caused harm to the patient.The customer returned an air dermatome device, serial number 101701, for evaluation.The customer also returned a hose and 1"/2"/3"/4" width plates, for evaluation.Dhr review: the device history record (dhr) review was unable to be performed as the dhr associated with this device is not available.This device was manufactured prior to (b)(6) 2009 where it was identified a robust dhr indexing and handling process was not in place.A corrective and preventative action (capa) implemented a serial number logbook to correct this issue.The previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The previous repair report review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (b)(6) two times as documented in the repair reports in livelink.The last repair was (b)(6) 2013 where it was reported that the device needed preventative maintenance and the ball detent, machined head, thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, poppet assembly, 1 inch/2inch/3 inch width plates, and o-ring were replaced.This is not a related issue.Device evaluations results/investigation findings: product review of the air dermatome on (b)(6) 2019 revealed that the calibration was out of specifications at all settings.The motor speed was within specifications.The control bar was low on the master blade on one side.All 4 with plates were dinged in the harvesting area as well as the leading edge.The device was left running and no heat was experienced.The control bar was dinged in the middle.The head was damaged in the blade area causing it to be difficult to insert the master blade during testing.Repair of the air dermatome has not been performed by zimmer biomet surgical as the device is aged and it is unknown if the customer will proceed or purchase a new unit.Probable cause/root cause: although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the malfunction.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information is available.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8775940
• MDR Text Key: 150558155
• Report Number: 0001526350-2019-00544
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 79